Field of the Invention
Embodiments of the invention relate generally to methods and compositions useful in enhancing female sexual arousal and for treating female sexual dysfunction. A preferred embodiment of the invention is directed to methods and compositions that utilize L-arginine or equivalents and/or derivatives thereof, and an agent that enhances the activity of the L-arginine or equivalent thereof. Such agents include niacin and nicotinamide. Not wishing to be bound by theory, it is believed that niacin and nicotinamide may function as agonists of Nitric Oxide Synthase (“NOS”). Accordingly, niacin and/or nicotinamide, in combination with arginine or its equivalent will allow a desired amount of nitric oxide (“NO”) to be delivered or generated at the female genitals in order to enhance sexual arousal and/or sexual pleasure and to treat sexual dysfunction.
Background Art
The female sexual experience is a complex phenomenon heavily influenced by emotional, psychological, relational, and physical modalities. Each individual female has specific needs and desires that involve all of the above or anyone factor at any given moment. Both sexual arousal and/or sexual pleasure are components of the female sexual experience.
Sexual dysfunction is also a complex and amorphous concept, but can refer to the failure to achieve anyone of the four phases of sexual response—appetite, excitement, orgasm, or resolution.
While prevalence of male sexual dysfunction is often cited in research and addressed by various pharmaceutical products, female sexual dysfunction (“FSD”) has been largely ignored. According to a 1999 report in the Journal of the American Medical Association, 43% of women suffer from FSD, significantly higher than the 31% prevalence of sexual dysfunction in men. It is difficult to effectively evaluate the female sexual response due to the complex emotional, relational, and physical variables that are associated with each encounter. Religious and cultural influences also play a role in the attitudes towards sex and this can complicate the sexual response as well. Despite the prevalence of women suffering from the condition, no FDA approved pharmaceutical treatment has been developed. In 2004, the FDA rejected fast-track approval of Proctor & Gamble's Intrinsa transdermal system (skin patch), a product aimed at decreasing FSD in surgically menopausal women, demonstrating the difficulty and expense in addressing concerns of safety and efficacy of drug therapy in this market. A recent study of 256 women using a topical botanical product called Zestra® demonstrated a favorable sexual response after topical application, but 14% displayed mild to moderate burning (Ferguson, D. M., 2010, Randomized placebo-controlled double-blind, parallel design trial of the efficacy and safety of Zestra® in women with mixed desire/interest/arousal/orgasm disorders, J. of Sex and Marital Therapy, 36:66-86).